FDA advisory committee backs approval of Sanofi drug for OTC

The US Food and Drug Administration’s Nonprescription Drugs Advisory Committee (NDAC) voted 10 to six, with two abstentions, recommending approval of French drug major Sanofi’s (Euronext: SAN) Nasacort AQ Nasal Spray (triamcinolone acetonide) for over-the-counter use in the USA.

“Today’s positive NDAC vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers,” said Charles Hugh-Jones, chief medical officer at Sanofi US, adding: “We appreciate the feedback from the Committee and look forward to working with FDA in completing its review.”

If approved by the FDA, Nasacort AQ would be first-in-class as an OTC medicine and marketed by Sanofi’s consumer health care division, Chattem, a company acquired by Sanofi in 2009 for $1.9 billion (The Pharma Letter December 22, 2009). The proposed OTC indication is temporary relief of nasal symptoms of hay fever or other upper respiratory allergies (allergic rhinitis) in adults and children 2 years of age and older.